MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.054S

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a hip surgery performed on an unknown date in 2020, the proximal femoral nail antorotation (pfna) blade detached and broke into two pieces while connecting to pfna impactor and interlocking mechanism failed.There was a fifteen (15) minutes surgical delay.The surgeon used another pfna blade.Surgery was completed.Concomitant device reported: unknown pfna impactor (product# unknown, lot# unknown, qty 1).This report is for one (1) pfna-ii blade l95 tan.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10: additional narrative: h3, h4, h6: part 04.027.054s, lot 3l65154: manufacturing site: bettlach.Release to warehouse date: february 28, 2019.Expiry date: february 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the pfna-ii blade l95 tan (part# 04.027.054s, lot# 3l65154 qty# 1) was returned and received at us cq.Upon visual inspection, it is observed that the device was received disassembled and the screw was fixed inappropriately within the end cap.The screw notch was facing outward and the hex was facing inward.No signs of any breakage were observed.The surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were noted with the returned device.Functional test: a complete functional test could not be performed as the mating devices were not returned.A partial functional test was performed on the locking mechanism of the helical blade.The screw which was received inappropriately fixed within the end cap was first disassembled from the sleeve and the end cap.The notch of the screw was then latched onto the notch of the helical blade, and was then assembled with the sleeve and the end cap.The end cap was then fastened.The end cap was able to lock all the way leaving no gaps between the sleeve and the blade.The blade could not rotate in the locked position.The components could also be unlocked and disassembled with no difficulty.The device functioned as intended.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq as the device functioned as intended.Document/specification review: the following drawing(s) (current and manufactured to) were reviewed: -blade l75-120mm, tan f/pfna-ii blade: se_193639 rev.C -end cap, tan f/pfna-ii blade: se_193633 rev.D -screw m7x1 tan/sst f/pfna blade: se_141065 rev.G -sleeve l43.5-63.5mm, tan f/pfna-ii blade: se_193613 rev.B no design issues or discrepancies were found during this investigation.Investigation conclusion: the overall complaint is being confirmed for the pfna-ii blade l95 tan (part# 04.027.054s, lot# 3l65154 qty# 1) as the device was inappropriately assembled prior to use.The locking mechanism of the device functioned as intended upon assembling the components correctly.The root cause for the reported issue is being attributed to use error.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part: 04.027.054s lot: 3l65154 manufacturing site: bettlach release to warehouse date: 28.Feb.2019 expiry date: 01.Feb.2029 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFNA-II BLADE L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11166962
• MDR Text Key: 227072649
• Report Number: 8030965-2021-00287
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 7611819394230
• UDI-Public: (01)7611819394230
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: 3L65154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 03/02/2021; 03/16/2021; 12/06/2021
• Supplement Dates FDA Received: 03/10/2021; 04/02/2021; 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PFNA IMPACTION INSTRUMENTS: TRAUMA