MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.053S

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was 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.After the surgery, the pfna-ii aiming arm and zig unable to detach from nail.Surgeons removed complete implants back and placed lcp-dhs.The surgery was completed successfully with 60-minutes delay.The patient outcome was unknown.Concomitant device reported: pfna-ii blades(part# 04.027.053s; lot# unknown; quantity: 1); locking screws stardrive b 5.0 mm, for medullary nails (part# 04.005.524; lot# unknown; quantity: 1); connector for pfn, for no.357.020 (part# 357.028; lot# unknown; quantity: 1); connecting screw, cannulated, for pfn and pfna (part# 357.029; lot# unknown; quantity: 1).This complaint three (3) devices.This report is for one (1) pfna-ii blade l90 tan.This is report 1 of 7 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: g4: device is not distributed in the united states, but is similar to device marketed in the usa.H6: health effect clinician code 2402 used to capture injury.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 L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12748673
• MDR Text Key: 280009826
• Report Number: 8030965-2021-09255
• Device Sequence Number: 1
• Product Code: HRS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.053S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONNEC F/PFN F/357.020; CONNECT-SCR-CANN F/PFN+PFNA; LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; PFNA-II Ø11 XS 130° L170 TAN; UNK - GUIDES/SLVS/AMNG: AIMING ARM; UNK - INSERTION INSTRUMENTS: TRAUMA; CONNEC F/PFN F/357.020; CONNECT-SCR-CANN F/PFN+PFNA; LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; PFNA-II Ø11 XS 130° L170 TAN; UNK - GUIDES/SLVS/AMNG: AIMING ARM; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Outcome(s): Required Intervention