MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L85 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.027.052S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4), expiration date unknown(10)lot number unknown.Date of implant is unknown.Since the device broke during removal and a portion remains in the patient, this device is not considered to have been explanted.It is unknown if the subject device will be returned to the manufacturer for evaluation.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during the removal of the proximal femur nail anterior blade (pfna-blade) on (b)(6) 2016, the tip of the blade broke and the entire device could not be removed from the patient.It was reported that the surgeon attached the extraction screw for the pfna-blade and used the sliding hammer gently to remove the blade.During extraction, the tip of the blade broke and the surgeon could not remove the whole blade.Only the edge of the blade was removed.The surgeon could not complete removal procedure.The patient's postoperative condition was stable.There was a surgical delay of unknown duration due to the reported event.The date the device was initially implanted the reason for device removal are also unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).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

The blade was not returned for evaluation.However, a pfna end cap, which is associated with one of the potential part numbers provided, was returned for evaluation on april 11, 2016.It was during the visual inspection of this device that the originally reported part number (04.027.052s) was determine to be inaccurate.Evaluation pertaining to received end cap (complainant part not received): the previously reported article (part 04.027.052s for pfna-ii blade l85 tan) does not correspond with the received pfna-ii blade component (end cap).Therefore, it is likely that actual pfna blade is either part 456.763s or 456.764s.Device history record reviews for all of the potential pfna-ii blades containing the received end cap within their constructs was conducted with no abnormalities detected.Since the specific circumstances regarding the method of use and handling during the operation are unknown, a root cause cannot be determined.Manufacturing dates: february 8, 2010 (lot 2571329) and february 15, 2010 (lots 2571331 and 2571328).A review of the device history records for each of the three (3) potential part/lot combinations was conducted with results as follows: part 456.763s / lot 2571331, manufacturing location: (b)(4) - manufacturing date: february 15, 2010 - expiry date: february 1, 2020.No non-conformance reports (ncr) were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Part 456.763s / lot 2571328, manufacturing location: (b)(4) - manufacturing date: february 15, 2010 - expiry date: february 1, 2020.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Part 456.764s / lot 2571329, manufacturing location: (b)(4) - manufacturing date: february 8, 2010 - expiry date: february 1, 2020.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.This report is for one (1) unknown pfna blade with potential part/lot combinations as follows: 456.763s / lot 2571331; 456.763s / lot 2571328; 456.764s / lot 2571329.Device 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.Construct component returned/evaluated.

Event Description

It was further reported that a ten (10) minute delay was encountered due to the intra-operative breakage of the blade.A portion of the device still remains in situ with no plans for removal.This report is for one (1) unknown pfna blade.This report is 1 of 1 for (b)(4).

• Brand Name: PFNA-II BLADE L85 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5488074
• MDR Text Key: 39927335
• Report Number: 2520274-2016-11544
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 04.027.052S
• Device Lot Number: 2561921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/25/2016; 04/21/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention