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

Catalog Number 04.027.054S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on that (b)(6) 2021, the patient underwent for a surgery.During the surgery, the pfna ii helical blade interlocking mechanism was failed.The locking options was failed.The surgery was successfully completed with 10-minutes delay.There were no patient consequences reported.This complaint involves one (1) device.This report is for (1) pfna-ii blade l95 tan.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H10 additional narrative: g4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: part: 04.027.054s; lot: 164p079; manufacturing site: bettlach; release to warehouse date: may 26, 2021; expiry date: may 01, 2031.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the pfna-ii blade l95 tan was returned and received at us customer quality (cq).Upon visual inspection, it is observed that one of the flutes was broken at the tip.Nicks/scratches were observed on the device indicating signs of use.No other issues were observed with the 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 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: pfna-ii blade l75-l120mm, tan; end cap, tan; screw m7x1 tan/sstf/pfna blade.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 as one of the flute tip was found to be broken.The locking mechanism functioned as intended.A root cause for the reported issue cannot be determined from the available information.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 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12442728
• MDR Text Key: 270410992
• Report Number: 8030965-2021-07577
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394230
• UDI-Public: (01)07611819394230
• 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
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• 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: 164P079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1